Rotavirus vaccine safety info - from manufacturers website.

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https://www.merckvaccines.com/rotateqProductPage_frmst.html

 

[A note about placebo controlled trials.. The placebo is not a sterile shot but a similar vaccine. Rotateq will shortly be in the Indian market. Beware!! It is a notorious vaccine. An earlier Rotavirus vaccine was pulled out because a large number of children died due to intestinal blockage. As the literature points out, this version too suffers the same risk. Some people just enjoy playing with the lives of children! - Jagannath.]

 

RotaTeq should not be administered to infants with a demonstrated history of hypersensitivity to the vaccine or any component of the vaccine. No safety or efficacy data are available for the administration of RotaTeq to infants who are potentially immunocompromised or to infants with a history of gastrointestinal disorders.

Over 71,000 infants were evaluated in 3 placebo-controlled clinical trials. Serious adverse events occurred in 2.4% of recipients of RotaTeq when compared to 2.6% of placebo recipients within the 42-day period of a dose of RotaTeq. Hematochezia reported as a serious adverse event for RotaTeq compared to placebo was <0.1% vs <0.1%. The most frequently reported serious adverse events for RotaTeq compared to placebo were bronchiolitis (0.6% vs 0.7%), gastroenteritis (0.2% vs 0.3%), pneumonia (0.2% vs 0.2%), fever (0.1% vs 0..1%), and urinary tract infection (0.1% vs 0.1%). In a subset of more than 11,000 infants in these trials, the presence of adverse events was reported for 42 days after each dose. Fever was observed at similar rates in vaccine and placebo recipients (42.6% vs 42.8%). Adverse events that occurred at a statistically higher incidence within 42 days of any dose among recipients of RotaTeq as compared with placebo recipients were diarrhea (24.1% vs 21.3%), vomiting (15.2% vs 13.6%), otitis media (14.5% vs 13.0%), nasopharyngitis (6.9% vs 5.8%), and bronchospasm (1.1% vs 0.7%)..

In post-marketing experience, cases of intussusception and Kawasaki disease have been reported in infants who have received RotaTeq.

RotaTeq may not protect all vaccine recipients against rotavirus. Before administering RotaTeq, please read the Prescribing Information and Patient Product Information.

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